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Clinical Trial

Stratafix vs. PDS (Fascial Closure RCT)

NCT: NCT07574086 · NOT_YET_RECRUITING

NCT IDNCT07574086
StatusNOT_YET_RECRUITING
Start Date2026-05-01
Completion2031-12-31

Brief Summary

This proposed prospective, randomized, single-blinded controlled trial will directly compare Stratafix anti-microbial barbed sutures and standard PDS sutures for fascial closure at the time of Cesarean delivery. Primary outcomes will include postoperative pain scores at 24 hours, 48 hours, and two weeks postpartum (both total pain and right-sided abdominal pain commonly associated with the knot from traditional fascial closure), as well as total opioid consumption (morphine milligram equivalents) for the first 48 hours. Secondary outcomes will include length of hospital stay, wound complications (e.g., infection, dehiscence), patient satisfaction measured per the standardized surgical satisfaction questionnaire (SSQ-8), time required for fascial closure (minutes from start to end of fascial closure), and surgical site infections. The hypothesis is that among women undergoing primary Cesarean delivery, fascial closure with barbed suture (Stratafix) will result in lower postoperative pain scores and reduced opioid (narcotic) consumption within the first 48 hours after surgery compared to closure with traditional monofilament suture (PDS).

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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